Safety and Tolerability Study of Ragweed SLIT Tablets
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 09/30/2010 |
| Primero enviado: | 10/12/2010 |
| Inscripción estimada enviada: | 10/18/2010 |
| Publicado por primera vez: | 10/19/2010 |
| Última actualización enviada: | 11/04/2010 |
| Última actualización publicada: | 11/06/2010 |
| Fecha de inicio real del estudio: | 12/31/2008 |
| Fecha estimada de finalización primaria: | 03/31/2009 |
| Fecha estimada de finalización del estudio: | 09/30/2009 |
Condición o enfermedad
Intervención / tratamiento
Drug: Sublingual tablet of ragweed pollen allergen extract
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Placebo Comparator: 1 | |
| Experimental: 2 |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - written consent - male or female subjects from 18 yo 60 years old and in general good health - for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method - symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years - sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening - FEV1 at least of 80% of predicted value at screening Exclusion Criteria: - past or current disease which, as judged by the investigator, may affect the outcome of this study - history of life-threatening asthma - asthma requiring daily treatment (whatever the pharmaceutical class) - pregnant or lactating women - subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study - symptoms during the treatment phase due to a sensitivity to a second allergen - subjects treated with ongoing immunotherapy with another allergen |
Salir
Medidas de resultado primarias
1. Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks [2 weeks]
Medidas de resultado secundarias
1. Immunological markers (IgE and IgG4) [2 weeks]
